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The NuVasive Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The growth rod conversion implants may be used with Armada, Reline 4.5-5.0 rod constructs ranging in diameter from 4.5mm to 6.35mm. The NuVasive Growth Rod Conversion Set is not intended to be used in conjunction with staples.

The NuVasive Growth Rod Conversion Set consists of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct that can be surgically lengthened on a periodic basis as the patient grows. Implant components are available in a variety sizes and can be rigidly locked into a variety of different rod diameters. The devices are manufactured from biocompatible medical grade titanium alloy.

The provided text is a 510(k) summary for a medical device (NuVasive® Growth Rod Conversion Set). It details the device's intended use, technological characteristics, and a comparison to predicate devices, but does not contain information regarding
acceptance criteria, specific performance claims (e.g., accuracy, sensitivity, specificity), or the details of a clinical study with human readers, ground truth establishment, or statistical analysis.

The document states:

• "No additional testing was provided to support usage for the non-fusion indication." (Page 5, Section G. Performance Data)
• "Testing previously performed for Reline System (K143684) and Reline 4.5-5.0 System (K170126) to support fusion applications included subject devices. Comparison to predicate devices indicated for growth rod conversion was performed." (Page 5, Section G. Performance Data)

This indicates that the submission relied on existing testing data for other devices (Reline System and Reline 4.5-5.0 System) that included components similar to the subject device, and a comparison to predicate devices. It does not describe a specific study conducted to prove the current device meets acceptance criteria in the way one might expect for a diagnostic or AI-powered device (e.g., performance metrics, clinical reader studies).

Therefore, it is not possible to provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, or MRMC studies based on the provided text. The device's substantial equivalence relies on demonstrating similar technological characteristics and intended use to existing predicate devices, rather than a new clinical performance study for this specific device clearance.

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